Home / 510(k) Clearances / K010981

510(k) K010981

GSA GENITO SENSORY ANALYZER by Medoc Ltd. Advanced Medical Systems — Product Code LLN

K010981 is an FDA 510(k) premarket notification submitted by Medoc Ltd. Advanced Medical Systems for the device "GSA GENITO SENSORY ANALYZER". The FDA issued a decision of Substantially Equivalent on September 20, 2001. The device falls under product code LLN (Device, Vibration Threshold Measurement), a Class I device regulated under 21 CFR 882.1200. Medoc Ltd. Advanced Medical Systems has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2001
Date Received
April 2, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vibration Threshold Measurement
Device Class
Class I
Regulation Number
882.1200
Review Panel
NE
Submission Type

Other clearances by Medoc Ltd. Advanced Medical Systems

  • K052357 — PATHWAY - ATS/CHEPS (January 19, 2006)
  • K051448 — MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS) (June 29, 2005)
  • K041908 — CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS) (February 25, 2005)

Other clearances for product code LLN

  • K072882 — PAIN VISION, MODEL PS-2100 (January 8, 2009)
  • K030829 — VPT METER (December 5, 2003)
  • K964622 — MEDI-DX 7000 (December 1, 1997)
  • K964815 — AP-4000, AIR PULSE SENSORY STIMULATOR (September 4, 1997)
  • K970180 — VSA 3000 VIBRATORYN SENSORY ANALYZER (April 25, 1997)
  • K934368 — NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 (August 11, 1994)
  • K921560 — VIBROTACTILE TESTER, MODEL NO. VTT-100 (October 30, 1992)
  • K910624 — CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 (January 17, 1992)
  • K872931 — TECA/MEDELEC TTT THERMAL THRESHOLD TESTER (November 16, 1987)
  • K863607 — VIBRATRON II, VIBRATION SENSITIVITY TESTER (December 3, 1986)

FDA data resources